510(k) K080392 ยท QEY Mechanical Thrombolysis Catheter
EndoWave Infusion System
| Applicant | Ekos Corp., Bothell WA, US |
| Decision | Substantially Equivalent, Apr 30, 2008 |
| Received | Feb 13, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080392
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.